System, Nuclear Magnetic Resonance Imaging
Product Code: LNH
Radiology Nuclear Magnetic Resonance Devices
Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co
Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]
Code of Federal Regulations: 892.1000
| Radiation Type | Microwave EMF |
| Radition Safety | None |
| Annual Reports | No |
| K223079 | Stage | SpinTech, Inc. |
| K222387 | Vantage Galan 3T, MRT-3020, V8.0 With AiCE Reconstruction Processing Unit For MR | Canon Medical Systems Corporation |
| K221923 | Swoop Portable MR Imaging System | Hyperfine, Inc. |
| K221393 | Swoop Portable MR Imaging System | Hyperfine, Inc. |
| K221025 | I_ Field 1.5T Superconducting Magnetic Resonance Imaging System | MRI Division,Beijing Wandong Medical Technology Co.,Ltd. |
| K220939 | MAGNETOM Lumina And MAGNETOM Vida Fit With Syngo MR XA50A | Siemens Medical Solutions USA Inc. |
| K220589 | MAGNETOM Skyra Fit | Siemens Medical Solutions USA, Inc. |
| K220575 | MAGNETOM Free.Max, MAGNETOM Free.Star | Siemens Medical Solutions USA, Inc. |
| K220425 | MAGNETOM Vida, MAGNETOM Sola | Siemens Medical Solutions USA, Inc. |
| K220332 | UMR Omega With UWS-MR-MRS | Shanghai United Imaging Healthcare Co.,Ltd. |
| K220192 | Vantage Galan 3T, MRT-3020, V8.0 With AiCE Reconstruction Processing Unit For MR | Canon Medical Systems Corporation |
| K220151 | MAGNETOM Avanto Fit | Siemens Medical Solutions USA, Inc. |
| K220018 | MR Elastography; MZEK-001A | Canon Medical Systems Corporation |
| K213717 | AIR Recon DL | GE Medical Systems,LLC (GE Healthcare) |
| K213693 | MAGNETOM Vida With Syngo MR XA50A | Siemens Medical Solutions USA, Inc. |
| 00613994719232 | System, nuclear magnetic resonance imaging |
| 00613994719225 | System, nuclear magnetic resonance imaging |
| 00613994703125 | System, nuclear magnetic resonance imaging |
| 00613994703118 | System, nuclear magnetic resonance imaging |
| 00613994670083 | System, nuclear magnetic resonance imaging |
| 00613994670069 | System, nuclear magnetic resonance imaging |
| 00613994670052 | System, nuclear magnetic resonance imaging |
| 00613994532107 | System, nuclear magnetic resonance imaging |
| 00613994532091 | System, nuclear magnetic resonance imaging |
| 00613994532053 | System, nuclear magnetic resonance imaging |
| 00613994532046 | System, nuclear magnetic resonance imaging |
| 00613994532039 | System, nuclear magnetic resonance imaging |
| 00613994532022 | System, nuclear magnetic resonance imaging |
| 00613994505002 | System, nuclear magnetic resonance imaging |
| 00613994463067 | System, nuclear magnetic resonance imaging |
| GE 1.5T SIGNA HDX MR SYSTEM | GE MEDICAL SYSTEMS, LLC | 2020-03-31 |
| INGENIA ELITION X | PHILIPS MEDICAL SYSTEMS NEDERLAND B. V. | 2020-03-27 |
| GENERAL ELECTRIC | GE MEDICAL SYSTEMS, LLC | 2020-03-20 |
| MRISYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING | UNKNOWN | 2020-03-19 |
| INGENIA 1.5T | PHILIPS ELECTRONICS NEDERLAND B.V. | 2020-03-17 |
| GE ARCHITECT | GE HEALTHCARE MANUFACTURING LLC. | 2020-03-12 |
| GE 1.5T SIGNA HDX MR SYSTEM | GE MEDICAL SYSTEMS, LLC | 2020-03-12 |
| DISCOVERY MR750W 3.0T | GE MEDICAL SYSTEMS, LLC | 2020-03-11 |
| MAGNETOM SKYRA | SIEMENS HEALTHCARE GMBH- MR | 2020-02-28 |
| MAGNETOM ESSENZA | SIEMENS SHENZHEN MAGNETIC RESONANCE LTD. | 2020-02-26 |
| ACHIEVA 1.5T NEW | PHILIPS ELECTRONICS NEDERLAND B.V. | 2020-02-25 |
| MAGNETOM SYMPHONY SYNGO MR | SIEMENS HEALTHCARE GMBH- MR | 2020-02-20 |
| INGENIA ELITION X | PHILIPS ELECTRONICS NEDERLAND B.V. | 2020-02-19 |
| QUADRATURE LOWER EXTREMITY COIL | INVIVO CORPORATION | 2020-02-10 |
| ACHIEVA XR 1.5T/3.0T | PHILIPS HEALTHCARE | 2020-02-05 |
| MAGNETOM SOLA | SIEMENS HEALTHCARE GMBH- MR | 2020-02-04 |
| GE 1.5T SIGNA HDX MR SYSTEM | GE MEDICAL SYSTEMS, LLC | 2020-01-28 |
| TESLA 1.5 MRI | UNK | 2020-01-24 |
| MAGNETOM AERA | SIEMENS HEALTHCARE GMBH- MR | 2020-01-20 |
| ACHIEVA 1.5T NEW | PHILIPS HEALTHCARE | 2020-01-20 |
| MAGNETOM AVANTO FIT | SIEMENS HEALTHCARE GMBH- MR | 2020-01-17 |
| SIGNA PIONEER | GE MEDICAL SYSTEMS, LLC | 2020-01-15 |
| SIGNA PIONEER | GE MEDICAL SYSTEMS, LLC | 2020-01-15 |
| MRI MACHINE | UNK | 2020-01-14 |
| CANON | CANON MEDICAL SYSTEMS CORPORATION | 2020-01-14 |
| GE MRI MACHINE - ARTIST | GENERAL ELECTRIC CO. | 2020-01-10 |
| 1.5T QUADRATURE LOWER EXTREMITY COIL | INVIVO CORPORATION | 2020-01-09 |
| SIEMENS AERA MRI UNIT | SIEMENS AG / SIEMENS HEALTHCARE GMBH | 2020-01-06 |
| DISCOVERY MR750W 3.0T | GE MEDICAL SYSTEMS, LLC | 2020-01-03 |
| MAGNETOM SKYRA FIT | SIEMENS HEALTHCARE GMBH | 2019-11-27 |
| ACHIEVA 1.5T NEW | PHILIPS HEALTHCARE | 2019-11-26 |
| 1.5T SIGNA HDXT | GE MEDICAL SYSTEMS, LLC | 2019-11-21 |
| MAGNETOM AVANTO DOT | SIEMENS HEALTHCARE GMBH | 2019-11-20 |
| MAGNETOM ESPREE | SIEMENS HEALTHCARE GMBH | 2019-11-14 |
| INGENIA 3.0T | PHILIPS HEALTHCARE | 2019-11-08 |
| SIGNA PIONEER | GE MEDICAL SYSTEMS, LLC | 2019-11-07 |
| SIEMENS AERA MRI SYSTEM | SIEMENS MEDICAL SOLUTIONS USA, INC. | 2019-11-01 |
| GE 1.5T SIGNA HDX MR SYSTEM | GE MEDICAL SYSTEMS, LLC | 2019-10-30 |
| ACHIEVA 1.5T NEW | PHILIPS HEALTHCARE | 2019-10-29 |
| INGENIA 3.0T | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2019-10-21 |
| INGENIA 1.5T | PHILIPS HEALTHCARE | 2019-10-17 |
| INGENIA ELITION X | PHILIPS HEALTHCARE | 2019-10-16 |
| MAGNETOM AERA | SIEMENS HEALTHCARE GMBH | 2019-10-15 |
| GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM | GE MEDICAL SYSTEMS, LLC | 2019-10-14 |
| MAGNETOM SKYRA | SIEMENS HEALTHCARE GMBH | 2019-10-14 |
| GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM | GE HANGWEI MEDICAL SYSTEMS CO., LTD. | 2019-10-09 |
| DISCOVERY MR450W 1.5T | GE MEDICAL SYSTEMS, LLC | 2019-10-03 |
| MRISYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGE | UNK | 2019-09-25 |
| ACHIEVA XR 1.5T/3.0T NEW | PHILIPS HEALTHCARE | 2019-09-25 |
| INGENIA 3.0T | PHILIPS HEALTHCARE | 2019-09-24 |